Principal Investigator - Clinical Research (Gastroenterologist) - Part Time/FT (0-8hr)
Denver, COFull-time, Part-time, and Contractor
150–250 an hour
Behavioral Health Market Context
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Benefits
Health Insurance
Job Description
clinical research trials. This position is ideal for a physician who wants to combine clinical expertise with scientific leadership in the conduct of gastrointestinal and hepatology research. The role involves oversight of all medical, ethical, and regulatory aspects of assigned clinical trials, ensuring data integrity and patient safety throughout each study phase.
Key Responsibilities
• Serve as Principal Investigator on gastroenterology-focused clinical trials (e.g., IBD, NASH, GERD, IBS, celiac disease, and other GI conditions).
• Provide medical leadership and ensure compliance with study protocols, ICH-GCP, FDA, and institutional regulations.
• Conduct screening evaluations, medical history reviews, and physical examinations to confirm subject eligibility.
• Oversee and interpret GI-related diagnostic assessments (e.g., endoscopic findings, liver function tests, imaging results).
• Ensure accurate adverse event (AE/SAE) identification, documentation, and timely reporting in alignment with sponsor and regulatory requirements.
• Collaborate with study coordinators, CRCs, CRAs, and regulatory teams to maintain data accuracy, timely enrollment, and protocol adherence.
• Participate in site initiation visits, monitoring visits, audits, and investigator meetings as the lead medical contact.
• Review and sign all source documentation, eCRFs, and study-related medical records to ensure data credibility.
• Contribute to protocol feasibility assessments and study design discussions to align with site capabilities and patient populations.
• Provide ongoing medical oversight during study conduct and ensure all safety assessments are completed per protocol.
• Maintain a high standard of ethical and patient-centered care, ensuring informed consent and subject well-being at every stage.
Requirements
• MD or DO degree with an active, unrestricted U.S. medical license (CO and/or IL preferred).
• Board certification in Gastroenterology required.
• Prior experience as a Principal Investigator or Sub-Investigator in clinical research preferred.
• Strong understanding of GCP, FDA, and ICH guidelines.
• Proficiency with EHR, EDC, and CTMS platforms.
• Excellent communication and leadership skills, with the ability to guide multidisciplinary research teams.
• DEA license and BLS/ACLS certification preferred.
Compensation & Benefits
• $150 – $250 per hour, based on experience and engagement type.
• Flexible scheduling – part-time or full-time options available.
• Opportunity to lead innovative clinical trials in gastroenterology and hepatology.
• Professional advancement in clinical research leadership and investigator development.
Key Responsibilities
• Serve as Principal Investigator on gastroenterology-focused clinical trials (e.g., IBD, NASH, GERD, IBS, celiac disease, and other GI conditions).
• Provide medical leadership and ensure compliance with study protocols, ICH-GCP, FDA, and institutional regulations.
• Conduct screening evaluations, medical history reviews, and physical examinations to confirm subject eligibility.
• Oversee and interpret GI-related diagnostic assessments (e.g., endoscopic findings, liver function tests, imaging results).
• Ensure accurate adverse event (AE/SAE) identification, documentation, and timely reporting in alignment with sponsor and regulatory requirements.
• Collaborate with study coordinators, CRCs, CRAs, and regulatory teams to maintain data accuracy, timely enrollment, and protocol adherence.
• Participate in site initiation visits, monitoring visits, audits, and investigator meetings as the lead medical contact.
• Review and sign all source documentation, eCRFs, and study-related medical records to ensure data credibility.
• Contribute to protocol feasibility assessments and study design discussions to align with site capabilities and patient populations.
• Provide ongoing medical oversight during study conduct and ensure all safety assessments are completed per protocol.
• Maintain a high standard of ethical and patient-centered care, ensuring informed consent and subject well-being at every stage.
Requirements
• MD or DO degree with an active, unrestricted U.S. medical license (CO and/or IL preferred).
• Board certification in Gastroenterology required.
• Prior experience as a Principal Investigator or Sub-Investigator in clinical research preferred.
• Strong understanding of GCP, FDA, and ICH guidelines.
• Proficiency with EHR, EDC, and CTMS platforms.
• Excellent communication and leadership skills, with the ability to guide multidisciplinary research teams.
• DEA license and BLS/ACLS certification preferred.
Compensation & Benefits
• $150 – $250 per hour, based on experience and engagement type.
• Flexible scheduling – part-time or full-time options available.
• Opportunity to lead innovative clinical trials in gastroenterology and hepatology.
• Professional advancement in clinical research leadership and investigator development.
Qualifications
- •Board certification in Gastroenterology required
- •Strong understanding of GCP, FDA, and ICH guidelines
- •Proficiency with EHR, EDC, and CTMS platforms
- •Excellent communication and leadership skills, with the ability to guide multidisciplinary research teams
Benefits
- •Compensation: $150 – $250 per hour (based on experience and contract type)
- •Schedule: Flexible | Part-Time (0–8 hours/week) or Full-Time options
- •Compensation & Benefits
- •$150 – $250 per hour, based on experience and engagement type
- •Flexible scheduling – part-time or full-time options available
- •Opportunity to lead innovative clinical trials in gastroenterology and hepatology
- •Professional advancement in clinical research leadership and investigator development
Responsibilities
- •This position is ideal for a physician who wants to combine clinical expertise with scientific leadership in the conduct of gastrointestinal and hepatology research
- •The role involves oversight of all medical, ethical, and regulatory aspects of assigned clinical trials, ensuring data integrity and patient safety throughout each study phase
- •Serve as Principal Investigator on gastroenterology-focused clinical trials (e.g., IBD, NASH, GERD, IBS, celiac disease, and other GI conditions)
- •Provide medical leadership and ensure compliance with study protocols, ICH-GCP, FDA, and institutional regulations
- •Conduct screening evaluations, medical history reviews, and physical examinations to confirm subject eligibility
- •Oversee and interpret GI-related diagnostic assessments (e.g., endoscopic findings, liver function tests, imaging results)
- •Ensure accurate adverse event (AE/SAE) identification, documentation, and timely reporting in alignment with sponsor and regulatory requirements
- •Collaborate with study coordinators, CRCs, CRAs, and regulatory teams to maintain data accuracy, timely enrollment, and protocol adherence
- •Participate in site initiation visits, monitoring visits, audits, and investigator meetings as the lead medical contact
- •Review and sign all source documentation, eCRFs, and study-related medical records to ensure data credibility
- •Contribute to protocol feasibility assessments and study design discussions to align with site capabilities and patient populations
- •Provide ongoing medical oversight during study conduct and ensure all safety assessments are completed per protocol
- •Maintain a high standard of ethical and patient-centered care, ensuring informed consent and subject well-being at every stage
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